Oral Care Compositions and Methods of Use

ABSTRACT

Described herein are oral care compositions comprising a basic amino acid; a combination of zinc ion sources; and from about 0.75 wt. % to about 2 wt. % of a chelating system; along with methods of making and using same.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority from PCT/CN2016/086994,filed Jun. 24, 2016, the contents of which are hereby incorporated byreference in their entirety.

BACKGROUND

The viscosity profile of most toothpastes either stabilize at the timeof production or show an increase in viscosity over time and/orstabilize within the product's shelf-life. However, certainarginine-based oral care compositions comprising cationic metal ions,e.g. zinc, exhibit a drop in viscosity and then stabilize within four toeight weeks after production. Maintaining the formula viscosity within acertain range is critical because viscosity impacts physical stabilityas well as processability.

As such, there remains a need to reconcile physical stability withprocessability. Certain embodiments of the present invention aredesigned to address this, and other, needs.

BRIEF SUMMARY

Some embodiments of the present invention provide oral care compositionscomprising a basic amino acid in free or salt wherein the amino acid isselected from arginine, lysine, and a combination thereof; a combinationof zinc ion sources; and a from about 1 wt. % to about 2 wt. % of achelating system. In some embodiments, the chelating system comprisestetrasodium pyrophosphate.

In some embodiments, the oral care compositions of the present inventiondemonstrate the ability to avoid viscosity loss over an extended periodof time, e.g. after 13 weeks.

In one aspect the invention is an oral care composition (Composition1.0) comprising:

-   -   a. A basic amino acid in free or salt from, wherein the amino        acid is selected from arginine, lysine, and combinations        thereof; (e.g., free form arginine);    -   b. zinc oxide and zinc citrate;    -   c. a fluoride source (e.g., sodium fluoride); and    -   d. a silica abrasive which exhibits an acid pH when measured as        an aqueous slurry (e.g., prophy silica).

For example, the invention contemplates any of the followingcompositions (unless otherwise indicated, values are given as percentageof the overall weight of the composition):

-   1.01 Composition 1.0 wherein the silica abrasive which exhibits an    acid pH when measured as an aqueous slurry is prophy silica.-   1.02 Any of the preceding compositions wherein the silica abrasive    which exhibits an acid pH when measured as an aqueous slurry is    Sylodent 783.-   1.03 Any of the preceding compositions wherein the silica abrasive    exhibits a pH of 3.5-4.5 in an aqueous slurry of the abrasive.-   1.04 Any of the preceding compositions wherein the silica abrasive    which exhibits an acid pH when measured as an aqueous slurry is    present in an amount from 2 to 35 weight percent.-   1.05 Any of the preceding compositions wherein the silica abrasive    which exhibits an acid pH when measured as an aqueous slurry is    present in an amount from 3 to 15 weight percent.-   1.06 Any of the preceding compositions wherein the silica abrasive    which exhibits an acid pH when measured as an aqueous slurry is    present in an amount selected from 2 wt. %, 3 wt. %, 4% wt. %, 5 wt.    %, 6 wt. %, 7 wt. %, 8 wt. %, 9 wt. %, 10 wt. %, 11 wt. %, 12 wt. %,    13 wt. %, 14 wt. %, 15 wt. %, 16 wt. %, 17 wt. %, 18 wt. %, 19 wt.    %, 20 wt. %.-   1.07 Any of the preceding compositions wherein the basic amino acid    has the L-configuration (e.g., L-arginine).-   1.08 Any of the preceding compositions wherein the basic amino acid    is arginine or lysine is in free form.-   1.09 Any of the preceding compositions wherein the basic amino acid    is provided in the form of a di- or tri-peptide comprising arginine    or lysine, or salts thereof.-   1.10 Any of the preceding compositions wherein the basic amino acid    is arginine or lysine, and wherein the arginine or lysine is present    in an amount corresponding to 1% to 15%, e.g., 3 wt. % to 10 wt. %    of the total composition weight, about e.g., 1.5%, 4%, 5%, or 8%,    wherein the weight of the basic amino acid is calculated as free    form.-   1.11 Any of the preceding compositions wherein the amino acid is    arginine from 0.1 wt. %-6.0 wt. %. (e.g., about 1.5 wt %).-   1.12 Any of the preceding compositions wherein the amino acid is    arginine from about 1.5 wt. %.-   1.13 Any of the preceding compositions wherein the amino acid is    arginine from 4.5 wt. %-8.5 wt. % (e.g., 5.0%).-   1.14 Any of the preceding compositions wherein the amino acid is    arginine from about 5.0 wt. %.-   1.15 Any of the preceding compositions wherein the amino acid is    arginine from 3.5 wt. %-9 wt. %.-   1.16 Any of the preceding compositions wherein the amino acid is    arginine from about 8.0 wt. %.-   1.17 Any of the preceding compositions wherein the amino acid is    L-arginine.-   1.18 Any of the preceding compositions wherein the amino acid is a    free form arginine.-   1.19 Any of the preceding compositions wherein the basic amino acid    is lysine (e.g., 2% wt., 3% wt., 4% wt., 5% wt., 6% wt.), (e.g., 4%    wt.).-   1.20 Any of the preceding compositions wherein the amino acid is    lysine from 1.0 wt. %-6.0 wt. %.-   1.21 Any of the preceding compositions wherein the amino acid is    lysine from about 1.5 wt. %.-   1.22 Any of the preceding compositions wherein the amino acid is    lysine from about 4.0 wt. %.-   1.23 Any of the preceding compositions wherein the amino acid is    L-lysine.-   1.24 Any of the preceding compositions wherein the amino acid is    free form lysine.-   1.25 Any of the preceding compositions wherein the amino acid is    arginine or lysine in partially or wholly in salt form.-   1.26 Composition 1.25 wherein the amino acid is arginine phosphate.-   1.27 Composition 1.25 wherein the amino acid is arginine    hydrochloride.-   1.28 Composition 1.25 wherein the amino acid is arginine    bicarbonate.-   1.29 Composition 1.25 wherein the amino acid is lysine phosphate.-   1.30 Composition 1.25 wherein the amino acid is lysine    hydrochloride.-   1.31 Composition 1.25 wherein the amino acid is lysine bicarbonate.-   1.32 Any of the preceding compositions wherein the amino acid is    arginine or lysine ionized by neutralization with an acid or a salt    of an acid.-   1.33 Any of preceding compositions wherein the composition is    ethanol-free.-   1.34 Any of the preceding compositions further comprising a fluoride    source selected from: stannous fluoride, sodium fluoride, potassium    fluoride, sodium monofluorophosphate, sodium fluorosilicate,    ammonium fluorosilicate, amine fluoride (e.g.,    N′-octadecyltrimethylendiamine-N,N,N′-tris(2-ethanol)-dihydrofluoride),    ammonium fluoride, titanium fluoride, hexafluorosulfate, and    combinations thereof.-   1.35 The composition of 1.34, wherein the fluoride source is    stannous fluoride.-   1.36 Any of the preceding compositions wherein the fluoride source    is a fluorophosphate.-   1.37 Any of the preceding compositions wherein the fluoride source    is sodium monofluorophosphate.-   1.38 The composition of 1.34, wherein the fluoride source is sodium    fluoride.-   1.39 Any of the preceding compositions wherein the fluoride source    is a fluoride salt present in an amount of 0.1 wt. % to 2 wt. % (0.1    wt %-0.6 wt. %) of the total composition weight (e.g., sodium    fluoride (e.g., about 0.32 wt. %) or sodium monofluorophosphate).-   1.40 Any of the preceding compositions wherein the fluoride source    is sodium fluoride in an amount about 0.32 wt. % based on the weight    of the composition.-   1.41 Any of the preceding compositions wherein the fluoride source    is a soluble fluoride salt which provides fluoride ion in an amount    of from 50 to 25,000 ppm (e.g., 750-2000 ppm, e.g., 1000-1500 ppm,    e.g., about 1000 ppm, e.g., about 1450 ppm)-   1.42 Any of the preceding compositions wherein the fluoride source    is sodium fluoride which provides fluoride in an amount from    750-2000 ppm (e.g., about 1450 ppm).-   1.43 Any of the preceding compositions wherein the fluoride source    is selected from sodium fluoride and sodium monofluorophosphate and    which provides fluoride in an amount from 1000 ppm-1500 ppm.-   1.44 Any of the preceding compositions wherein the fluoride source    is sodium fluoride or sodium monofluorophosphate and which provides    fluoride in an amount of about 1450 ppm.-   1.45 Any of the preceding compositions wherein the pH is between 6.0    and 10.5, e.g., 7.0 to 9.0, e.g., about 8.0.-   1.46 Any of the preceding compositions further comprising calcium    carbonate.-   1.47 The composition of 1.46, wherein the calcium carbonate is a    precipitated calcium carbonate high absorption (e.g., 20% to 30% by    weight of the composition) (e.g., 25% precipitated calcium carbonate    high absorption).-   1.48 The composition of 1.47, further comprising a precipitated    calcium carbonate-light (e.g., about 10% precipitated calcium    carbonate-light) (e.g., about 10% natural calcium carbonate).-   1.49 Any of the preceding compositions further comprising an    effective amount of one or more alkali phosphate salts, e.g.,    sodium, potassium or calcium salts, e.g., selected from alkali    dibasic phosphate and alkali pyrophosphate salts, e.g., alkali    phosphate salts selected from sodium phosphate dibasic, potassium    phosphate dibasic, dicalcium phosphate dihydrate, calcium    pyrophosphate, tetrasodium pyrophosphate, tetrapotassium    pyrophosphate, sodium tripolyphosphate, disodium    hydrogenorthophoshpate, monosodium phosphate, pentapotassium    triphosphate and mixtures of any of two or more of these, in an    amount of 0.1-20%, e.g., 0.1-8%, e.g., e.g., 0.2 to 5%, e.g., 0.3 to    2%, e.g., 0.3 to 1%, e.g about 0.5%, about 1%, about 2%, about 5%,    about 6%, by weight of the composition.-   1.50 Any of the preceding compositions comprising tetrapotassium    pyrophosphate, disodium hydrogenorthophosphate, monosodium    phosphate, and pentapotassium triphosphate.-   1.51 Any of the preceding compositions, wherein the composition    further comprises stannous pyrophosphate, wherein the stannous    pyrophosphate is from 0.1%-3% by wt. of the composition. (e.g.,    about 1% by wt. of the composition).-   1.52 Any of the preceding compositions comprising a polyphosphate.-   1.53 The composition of 1.49, wherein the polyphosphate is    tetrasodium pyrophosphate.-   1.54 The composition of 1.53, wherein the tetrasodium pyrophosphate    is from 0.1-1.0 wt % (e.g., about 0.5 wt %).-   1.55 Any of the preceding compositions further comprising a second    abrasive or particulate (e.g., silica).-   1.56 Any of the preceding compositions wherein the second abrasive    silica is synthetic amorphous silica. (e.g., 1%-28% by wt.) (e.g.,    8%-25% by wt.)-   1.57 Any of the preceding composition wherein the silica abrasives    are silica gels or precipitated amorphous silicas, e.g. silicas    having an average particle size ranging from 2.5 microns to 12    microns.-   1.58 Any of the preceding compositions further comprising a small    particle silica having a median particle size (d50) of 1-5 microns    (e.g., 3-4 microns) (e.g., about 5 wt. % Sorbosil AC43 from PQ    Chemicals, Warrington, United Kingdom).-   1.59 Any of the preceding compositions wherein 20-30 wt % of the    total silica in the composition is small particle silica (e.g.,    having a median particle size (d50) of 3-4 microns) and wherein the    small particle silica is about 5 wt. % of the oral care composition.-   1.60 Any of the preceding compositions comprising silica wherein the    silica is used as a thickening agent, e.g., particle silica.-   1.61 Any of the preceding compositions further comprising a nonionic    surfactant, wherein the nonionic surfactant is in an amount of from    0.5-5%, e.g, 1-2%, selected from poloxamers (e.g., poloxamer 407),    polysorbates (e.g., polysorbate 20), polyoxyl hydrogenated castor    oil (e.g., polyoxyl 40 hydrogenated castor oil), and mixtures    thereof.-   1.62 Any of the preceding compositions, wherein the poloxamer    nonionic surfactant has an average polyoxypropylene molecular mass    (Mw) of from 3000 to 5000 g/mol and a polyoxyethylene content of    from 60 to 80 mol %, e.g., the poloxamer nonionic surfactant    comprises poloxamer 407.-   1.63 Any of the preceding compositions further comprising glycerin,    wherein the glycerin is in a total amount of 25-40% (e.g., about    35%).-   1.64 The composition of 1.63, wherein the glycerin is in an amount    of about 35% by wt. of the composition.-   1.65 The composition of 1.63, wherein the glycerin is in an amount    of about 26% by wt. of the composition.-   1.66 Any of the preceding compositions further comprising sorbitol,    wherein the sorbitol is in a total amount of 10-40% (e.g., about    23%).-   1.67 The composition of 1.66, wherein the sorbitol is in an amount    of about 13% by wt. of the composition.-   1.68 The composition of any of 1.63-1.67, wherein the glycerin is an    amount of about 26% by wt., and the sorbitol is in an amount of    about 13% by wt.-   1.69 Any of the preceding compositions, wherein the ratio of the    amount of zinc oxide (e.g., wt. %) to zinc citrate (e.g., wt %) is    from 1.5:1 to 4.5:1 (e.g., 2:1, 2.5:1, 3:1, 3.5:1, or 4:1).-   1.70 Any of the preceding compositions, wherein the zinc citrate is    in an amount of from 0.25 to 1.0 wt % (e.g., 0.5 wt. %) and zinc    oxide may be present in an amount of from 0.75 to 1.25 wt % (e.g.,    1.0 wt. %) based on the weight of the oral care composition.-   1.71 Any of the preceding compositions wherein the zinc citrate is    about 0.5 wt %.-   1.72 Any of the preceding compositions wherein the zinc oxide is    about 1.0 wt %.-   1.73 Any of the preceding compositions where the zinc citrate is    about 0.5 wt % and the zinc oxide is about 1.0 wt %.-   1.74 Any of the preceding compositions further comprising an    additional ingredient selected from: benzyl alcohol,    Methylisothizolinone (“MIT”), Sodium bicarbonate, sodium methyl    cocoyl taurate (tauranol), lauryl alcohol, and polyphosphate.-   1.75 Any of the preceding compositions wherein the benzyl alcohol is    present from 0.1-0.6 wt %., (e.g., 0.1-0.4 wt %) e.g. about 0.1 wt.    %, about 0.2 wt. %, or about 0.3 wt. %.-   1.76 Any of the preceding compositions wherein the benzyl alcohol is    about 0.1 wt %.-   1.77 Any of the preceding compositions wherein the benzyl alcohol is    considered a preservative.-   1.78 Any of the preceding compositions comprising polymer films.-   1.79 Any of the preceding compositions comprising flavoring,    fragrance and/or coloring.-   1.80 The composition of 1.65, wherein the flavoring agent is sodium    saccharin, sucralose, or a mixture thereof-   1.81 Any of the preceding compositions, wherein the composition    comprises a thickening agents selected from the group consisting of    carboxyvinyl polymers, xanthan gum, carrageenan, hydroxyethyl    cellulose and water soluble salts of cellulose ethers (e.g., sodium    carboxymethyl cellulose and sodium carboxymethyl hydroxyethyl    cellulose).-   1.82 Any of the preceding compositions, wherein the compositions    comprises sodium carboxymethyl cellulose (e.g., from 0.5 wt. %-1.5    wt. %).-   1.83 Any of the preceding compositions comprising from 5%-40%, e.g.,    10%-35%, e.g., about 15%, 25%, 30%, and 35% water.-   1.84 Any of the preceding compositions comprising an additional    antibacterial agent selected from halogenated diphenyl ether (e.g.    triclosan), herbal extracts and essential oils (e.g., rosemary    extract, tea extract, magnolia extract, thymol, menthol, eucalyptol,    geraniol, carvacrol, citral, honokiol, catechol, methyl salicylate,    epigallocatechin gallate, epigallocatechin, gallic acid, miswak    extract, sea-buckthorn extract), bisguanide antiseptics (e.g.,    chlorhexidine, alexidine or octenidine), quaternary ammonium    compounds (e.g., cetylpyridinium chloride (CPC), benzalkonium    chloride, tetradecylpyridinium chloride (TPC),    N-tetradecyl-4-ethylpyridinium chloride (TDEPC)), phenolic    antiseptics, hexetidine, octenidine, sanguinarine, povidone iodine,    delmopinol, salifluor, metal ions (e.g., zinc salts and zinc    compounds, for example, Zinc Chloride, Zinc Lactate, Zinc Sulfate,    Zinc Oxide, stannous salts, copper salts, iron salts), sanguinarine,    propolis and oxygenating agents (e.g., hydrogen peroxide, buffered    sodium peroxyborate or peroxycarbonate), phthalic acid and its    salts, monoperthalic acid and its salts and esters, ascorbyl    stearate, oleoyl sarcosine, alkyl sulfate, dioctyl sulfosuccinate,    salicylanilide, domiphen bromide, delmopinol, octapinol and other    piperidino derivatives, nicin preparations, chlorite salts; and    mixtures of any of the foregoing.-   1.85 Any of the preceding compositions comprising an antioxidant,    e.g., selected from the group consisting of Co-enzyme Q10, PQQ,    Vitamin C, Vitamin E, Vitamin A, BHT, anethole-dithiothione, and    mixtures thereof-   1.86 Any of the preceding compositions comprising a whitening agent.-   1.87 Any of the preceding compositions comprising a whitening agent    selected from a whitening active selected from the group consisting    of peroxides, metal chlorites, perborates, percarbonates,    peroxyacids, hypochlorites, and combinations thereof.-   1.88 Any of the preceding compositions further comprising hydrogen    peroxide or a hydrogen peroxide source, e.g., urea peroxide or a    peroxide salt or complex (e.g., such as peroxyphosphate,    peroxycarbonate, perborate, peroxysilicate, or persulphate salts;    for example calcium peroxyphosphate, sodium perborate, sodium    carbonate peroxide, sodium peroxyphosphate, and potassium    persulfate), or hydrogen peroxide polymer complexes such as hydrogen    peroxide-polyvinyl pyrrolidone polymer complexes.-   1.89 Any of the preceding compositions further comprising an agent    that interferes with or prevents bacterial attachment, e.g., ethyl    lauryl arginate (ELA) or chitosan.-   1.90 Any of the preceding compositions comprising:    -   a. about 1.0% zinc oxide    -   b. about 0.5% zinc citrate    -   c. about 1.5% L-arginine    -   d. about 0.32% sodium fluoride;    -   e. about 3 wt. % to 15 wt. % silica abrasive which exhibits an        acid pH when measured as an aqueous slurry (e.g., prophy silica)        (e.g., Sylodent 783)-   1.91 Any of the preceding compositions comprising:    -   a. about 1.0% zinc oxide    -   b. about 0.5% zinc citrate    -   c. about 5% L-arginine    -   d. about 0.32% sodium fluoride    -   e. about 10 wt. % to 15 wt. % silica abrasive which exhibits an        acid pH when measured as an aqueous slurry (e.g., prophy silica)        (e.g., Sylodent 783), and-   1.92 Any of the preceding compositions comprising:    -   a. about 1.0% zinc oxide    -   b. about 0.5% zinc citrate    -   c. about 5% L-arginine    -   d. about 0.32% sodium fluoride;    -   e. about 3 wt. % to 15 wt. % silica abrasive which exhibits an        acid pH when measured as an aqueous slurry. (e.g., prophy        silica) (e.g., Sylodent 783)-   1.93 Any of the preceding compositions comprising a silica, wherein    the silica is Zeodent 114.-   1.94 Any of the preceding compositions effective upon application to    the oral cavity, e.g., by rinsing, optionally in conjunction with    brushing, to (i) reduce or inhibit formation of dental caries, (ii)    reduce, repair or inhibit pre-carious lesions of the enamel, e.g.,    as detected by quantitative light-induced fluorescence (QLF) or    electrical caries measurement (ECM), (iii) reduce or inhibit    demineralization and promote remineralization of the teeth, (iv)    reduce hypersensitivity of the teeth, (v) reduce or inhibit    gingivitis, (vi) promote healing of sores or cuts in the    mouth, (vii) reduce levels of acid producing bacteria, (viii) to    increase relative levels of arginolytic bacteria, (ix) inhibit    microbial biofilm formation in the oral cavity, (x) raise and/or    maintain plaque pH at levels of at least pH 5.5 following sugar    challenge, (xi) reduce plaque accumulation, (xii) treat, relieve or    reduce dry mouth, (xiii) clean the teeth and oral cavity (xiv)    reduce erosion, (xv) prevents stains and/or whiten teeth, (xvi)    immunize the teeth against cariogenic bacteria; and/or (xvii)    promote systemic health, including cardiovascular health, e.g., by    reducing potential for systemic infection via the oral tissues.-   1.95 Any of the preceding oral compositions, wherein the oral    composition may be any of the following oral compositions selected    from the group consisting of: a toothpaste or a dentifrice, a    mouthwash or a mouth rinse, a topical oral gel, and a denture    cleanser.-   1.96 A composition obtained or obtainable by combining the    ingredients as set forth in any of the preceding compositions.-   1.97 A composition obtained or obtainable by combining the    ingredients as set forth in any of the preceding compositions.-   1.98 A composition for use as set for in any of the preceding    compositions.

In another embodiment, the invention encompasses a method to improveoral health comprising applying an effective amount of the oralcomposition of any of the embodiments set forth above (e.g., any ofComposition 1.0 et seq) to the oral cavity of a subject in need thereof,e.g.,

-   -   i. a method to reduce or inhibit formation of dental caries,        reduce, repair or inhibit early enamel lesions, e.g., as        detected by quantitative light-induced fluorescence (QLF) or        electrical caries measurement (ECM),    -   ii. reduce or inhibit demineralization and promote        remineralization of the teeth,    -   iii. reduce hypersensitivity of the teeth,    -   iv. reduce or inhibit gingivitis,    -   v. promote healing of sores or cuts in the mouth,    -   vi. reduce levels of acid producing bacteria,    -   vii. to increase relative levels of arginolytic bacteria,    -   viii. inhibit microbial bio film formation in the oral cavity,    -   ix. raise and/or maintain plaque pH at levels of at least pH 5.5        following sugar challenge,    -   x. reduce plaque accumulation,    -   xi. treat dry mouth,    -   xii. enhance systemic health, including cardiovascular health,        e.g., by reducing potential for systemic infection via the oral        tissues,    -   xiii. Whiten teeth,    -   xiv. reduce erosion of the teeth,    -   xv. immunize (or protect) the teeth against cariogenic bacteria        and their effects, and/or    -   xvi. clean the teeth and oral cavity.

The invention further comprises the use of sodium bicarbonate, sodiummethyl cocoyl taurate (tauranol), methylisothiazolinone, and benzylalcohol and combinations thereof in the manufacture of a Composition ofthe Invention, e.g., for use in any of the indications set forth in theabove method of Composition 1.0, et seq.

DETAILED DESCRIPTION

As used herein, the term “oral composition” means the total compositionthat is delivered to the oral surfaces. The composition is furtherdefined as a product which, during the normal course of usage, is not,the purposes of systemic administration of particular therapeuticagents, intentionally swallowed but is rather retained in the oralcavity for a time sufficient to contact substantially all of the dentalsurfaces and/or oral tissues for the purposes of oral activity. Examplesof such compositions include, but are not limited to, toothpaste or adentifrice, a mouthwash or a mouth rinse, a topical oral gel, a denturecleanser, and the like.

As used herein, the term “dentifrice” means paste, gel, or liquidformulations unless otherwise specified. The dentifrice composition canbe in any desired form such as deep striped, surface striped,multi-layered, having the gel surrounding the paste, or any combinationthereof. Alternatively the oral composition is provided as a dual phasecomposition, wherein individual compositions are combined when dispensedfrom a separated compartment dispenser.

Basic Amino Acids

The basic amino acids which can be used in the compositions and methodsof the invention include not only naturally occurring basic amino acids,such as arginine, lysine, and histidine, but also any basic amino acidshaving a carboxyl group and an amino group in the molecule, which arewater-soluble and provide an aqueous solution with a pH of 7 or greater.

Accordingly, basic amino acids include, but are not limited to,arginine, lysine, serine, citrullene, ornithine, creatine, histidine,diaminobutanoic acid, diaminoproprionic acid, salts thereof orcombinations thereof. In a particular embodiment, the basic amino acidsare selected from arginine, citrullene, and ornithine.

In certain embodiments, the basic amino acid is arginine, for example,L-arginine, or a salt thereof.

The compositions of the invention are intended for topical use in themouth and so salts for use in the present invention should be safe forsuch use, in the amounts and concentrations provided. Suitable saltsinclude salts known in the art to be pharmaceutically acceptable saltswhich are generally considered to be physiologically acceptable in theamounts and concentrations provided. Physiologically acceptable saltsinclude those derived from pharmaceutically acceptable inorganic ororganic acids or bases, for example acid addition salts formed by acidswhich form a physiological acceptable anion, e.g., hydrochloride orbromide salt, and base addition salts formed by bases which form aphysiologically acceptable cation, for example those derived from alkalimetals such as potassium and sodium or alkaline earth metals such ascalcium and magnesium. Physiologically acceptable salts may be obtainedusing standard procedures known in the art, for example, by reacting asufficiently basic compound such as an amine with a suitable acidaffording a physiologically acceptable anion.

Fluoride Ion Source

The oral care compositions may further include one or more fluoride ionsources, e.g., soluble fluoride salts. A wide variety of fluorideion-yielding materials can be employed as sources of soluble fluoride inthe present compositions. Examples of suitable fluoride ion-yieldingmaterials are found in U.S. Pat. No. 3,535,421, to Briner et al.; U.S.Pat. No. 4,885,155, to Parran, Jr. et al. and U.S. Pat. No. 3,678,154,to Widder et al., each of which are incorporated herein by reference.Representative fluoride ion sources used with the present invention(e.g., Composition 1.0 et seq.) include, but are not limited to,stannous fluoride, sodium fluoride, potassium fluoride, sodiummonofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate,amine fluoride, ammonium fluoride, and combinations thereof. In certainembodiments the fluoride ion source includes stannous fluoride, sodiumfluoride, sodium monofluorophosphate as well as mixtures thereof. Wherethe formulation comprises calcium salts, the fluoride salts arepreferably salts wherein the fluoride is covalently bound to anotheratom, e.g., as in sodium monofluorophosphate, rather than merelyionically bound, e.g., as in sodium fluoride.

Surfactants

The invention may in some embodiments contain anionic surfactants, e.g.,the Compositions of Composition 1.0, et seq., for example, water-solublesalts of higher fatty acid monoglyceride monosulfates, such as thesodium salt of the monosulfated monoglyceride of hydrogenated coconutoil fatty acids such as sodium N-methyl N-cocoyl taurate, sodiumcoco-glyceride sulfate; higher alkyl sulfates, such as sodium laurylsulfate; higher alkyl-ether sulfates, e.g., of formulaCH₃(CH₂)_(m)CH₂(OCH₂CH₂)_(n)OS0₃X, wherein m is 6-16, e.g., 10, n is1-6, e.g., 2, 3 or 4, and X is Na or, for example sodium laureth-2sulfate (CH₃(CH₂)₁₀CH₂(OCH₂CH₂)₂OS0₃Na); higher alkyl aryl sulfonatessuch as sodium dodecyl benzene sulfonate (sodium lauryl benzenesulfonate); higher alkyl sulfoacetates, such as sodium laurylsulfoacetate (dodecyl sodium sulfoacetate), higher fatty acid esters of1,2 dihydroxy propane sulfonate, sulfocolaurate (N-2-ethyl lauratepotassium sulfoacetamide) and sodium lauryl sarcosinate. By “higheralkyl” is meant, e.g., C₆₋₃o alkyl. In particular embodiments, theanionic surfactant (where present) is selected from sodium laurylsulfate and sodium ether lauryl sulfate. When present, the anionicsurfactant is present in an amount which is effective, e.g., >0.001% byweight of the formulation, but not at a concentration which would beirritating to the oral tissue, e.g., 1%, and optimal concentrationsdepend on the particular formulation and the particular surfactant. Inone embodiment, the anionic surfactant is present at from 0.03% to 5% byweight, e.g., 1.5%.

Cationic surfactants useful in the present invention can be broadlydefined as derivatives of aliphatic quaternary ammonium compounds havingone long alkyl chain containing 8 to 18 carbon atoms such as lauryltrimethylammonium chloride, cetyl pyridinium chloride, cetyltrimethylammonium bromide, di-isobutylphenoxyethyldimethylbenzylammoniumchloride, coconut alkyltrimethylammonium nitrite, cetyl pyridiniumfluoride, and mixtures thereof. Illustrative cationic surfactants arethe quaternary ammonium fluorides described in U.S. Pat. No. 3,535,421,to Briner et al., herein incorporated by reference. Certain cationicsurfactants can also act as germicides in the compositions.

Illustrative nonionic surfactants of Composition 1.0, et seq., that canbe used in the compositions of the invention can be broadly defined ascompounds produced by the condensation of alkylene oxide groups(hydrophilic in nature) with an organic hydrophobic compound which maybe aliphatic or alkylaromatic in nature. Examples of suitable nonionicsurfactants include, but are not limited to, the Pluronics, polyethyleneoxide condensates of alkyl phenols, products derived from thecondensation of ethylene oxide with the reaction product of propyleneoxide and ethylene diamine, ethylene oxide condensates of aliphaticalcohols, long chain tertiary amine oxides, long chain tertiaryphosphine oxides, long chain dialkyl sulfoxides and mixtures of suchmaterials. In a particular embodiment, the composition of the inventioncomprises a nonionic surfactant selected from polaxamers (e.g.,polaxamer 407), polysorbates (e.g., polysorbate 20), polyoxylhydrogenated castor oils (e.g., polyoxyl 40 hydrogenated castor oil),and mixtures thereof.

Illustrative amphoteric surfactants of Composition 1.0, et seq., thatcan be used in the compositions of the invention include betaines (suchas cocamidopropylbetaine), derivatives of aliphatic secondary andtertiary amines in which the aliphatic radical can be a straight orbranched chain and wherein one of the aliphatic substituents containsabout 8-18 carbon atoms and one contains an anionic water-solubilizinggroup (such as carboxylate, sulfonate, sulfate, phosphate orphosphonate), and mixtures of such materials.

Illustrative zwitterionic surfactants of Composition 1.0, et seq., thatcan be used in the compositions of the invention include derivatives ofaliphatic quaternary ammonium, phosphonium and sulfonium compounds inwhich the aliphatic radical can be a straight or branched chain andwherein one of the aliphatic substituents contains about 8-18 carbonatoms and one contains an anionic water-solubilizing group (such ascarboxy, sulfonate, sulfate, phosphate or phosphonate). The surfactantor mixtures of compatible surfactants can be present in the compositionsof the present invention in 0.1% to 5%, in another embodiment 0.3% to 3%and in another embodiment 0.5% to 2% by weight of the total composition.

Flavoring Agents

The oral care compositions of the invention may also include a flavoringagent. Flavoring agents which are used in the practice of the presentinvention include, but are not limited to, essential oils and variousflavoring aldehydes, esters, alcohols, and similar materials, as well assweeteners such as sodium saccharin. Examples of the essential oilsinclude oils of spearmint, peppermint, wintergreen, sassafras, clove,sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, andorange. Also useful are such chemicals as menthol, carvone, andanethole. Certain embodiments employ the oils of peppermint andspearmint.

The flavoring agent is incorporated in the oral composition at aconcentration of 0.01 to 1% by weight.

Chelating and Anti-Calculus Agents

The oral care compositions of the invention (e.g., Composition 1.0 etseq) also may include one or more chelating agents able to complexcalcium found in the cell walls of the bacteria. Binding of this calciumweakens the bacterial cell wall and augments bacterial lysis.

Another group of agents suitable for use as chelating or anti-calculusagents in the present invention are the soluble pyrophosphates. Thepyrophosphate salts used in the present compositions can be any of thealkali metal pyrophosphate salts. In certain embodiments, salts includetetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate,trialkali metal monoacid pyrophosphate and mixtures thereof, wherein thealkali metals are sodium or potassium. The salts are useful in boththeir hydrated and unhydrated forms. An effective amount ofpyrophosphate salt useful in the present composition is generally enoughto provide least 0.1 wt. % pyrophosphate ions, e.g., 0.1 to 3 wt 5,e.g., 0.1 to 2 wt %, e.g., 0.1 to 1 wt %, e.g., 0.2 to 0.5 wt %. Thepyrophosphates also contribute to preservation of the compositions bylowering the effect of water activity.

Polymers

The oral care compositions of the invention (e.g., Composition 1.0, etseq) also optionally include one or more polymers, such as polyethyleneglycols, polyvinyl methyl ether maleic acid copolymers, polysaccharides(e.g., cellulose derivatives, for example carboxymethyl cellulose, orpolysaccharide gums, for example xanthan gum or carrageenan gum). Acidicpolymers, for example polyacrylate gels, may be provided in the form oftheir free acids or partially or fully neutralized water soluble alkalimetal (e.g., potassium and sodium) or ammonium salts. Certainembodiments include 1:4 to 4:1 copolymers of maleic anhydride or acidwith another polymerizable ethylenically unsaturated monomer, forexample, methyl vinyl ether (methoxyethylene) having a molecular weight(M.W.) of about 30,000 to about 1,000,000. These copolymers areavailable for example as Gantrez AN 139 (M.W. 500,000), AN 1 19 (M.W.250,000) and S-97 Pharmaceutical Grade (M.W. 70,000), of GAF ChemicalsCorporation.

Other operative polymers include those such as the 1:1 copolymers ofmaleic anhydride with ethyl acrylate, hydroxyethyl methacrylate,N-vinyl-2-pyrollidone, or ethylene, the latter being available forexample as Monsanto EMA No. 1 103, M.W. 10,000 and EMA Grade 61, and 1:1copolymers of acrylic acid with methyl or hydroxyethyl methacrylate,methyl or ethyl acrylate, isobutyl vinyl ether or N-vinyl-2-pyrrolidone.

Suitable generally, are polymerized olefinically or ethylenicallyunsaturated carboxylic acids containing an activated carbon-to-carbonolefinic double bond and at least one carboxyl group, that is, an acidcontaining an olefinic double bond which readily functions inpolymerization because of its presence in the monomer molecule either inthe alpha-beta position with respect to a carboxyl group or as part of aterminal methylene grouping. Illustrative of such acids are acrylic,methacrylic, ethacrylic, alpha-chloroacrylic, crotonic, beta-acryloxypropionic, sorbic, alpha-chlorosorbic, cinnamic, beta-styrylacrylic,muconic, itaconic, citraconic, mesaconic, glutaconic, aconitic,alpha-phenylacrylic, 2-benzyl acrylic, 2-cyclohexylacrylic, angelic,umbellic, fumaric, maleic acids and anhydrides. Other different olefinicmonomers copolymerizable with such carboxylic monomers includevinylacetate, vinyl chloride, dimethyl maleate and the like. Copolymerscontain sufficient carboxylic salt groups for water-solubility.

A further class of polymeric agents includes a composition containinghomopolymers of substituted acrylamides and/or homopolymers ofunsaturated sulfonic acids and salts thereof, in particular wherepolymers are based on unsaturated sulfonic acids selected fromacrylamidoalykane sulfonic acids such as 2-acrylamide 2 methylpropanesulfonic acid having a molecular weight of about 1,000 to about2,000,000, described in U.S. Pat. No. 4,842,847, Jun. 27, 1989 to Zahid,incorporated herein by reference.

Another useful class of polymeric agents includes polyamino acids,particularly those containing proportions of anionic surface-activeamino acids such as aspartic acid, glutamic acid and phosphoserine, asdisclosed in U.S. Pat. No. 4,866,161 Sikes et al., incorporated hereinby reference.

In preparing oral care compositions, it is sometimes necessary to addsome thickening material to provide a desirable consistency or tostabilize or enhance the performance of the formulation. In certainembodiments, the thickening agents are carboxyvinyl polymers,carrageenan, xanthan gum, hydroxyethyl cellulose and water soluble saltsof cellulose ethers such as sodium carboxymethyl cellulose and sodiumcarboxymethyl hydroxyethyl cellulose. Natural gums such as karaya, gumarabic, and gum tragacanth can also be incorporated. Colloidal magnesiumaluminum silicate or finely divided silica can be used as component ofthe thickening composition to further improve the composition's texture.In certain embodiments, thickening agents in an amount of about 0.5% toabout 5.0% by weight of the total composition are used.

Abrasives

Generally, the inclusion of abrasives in dentifrice formulations isnecessary for effective cleaning of teeth by brushing. It has beendetermined that by including an abrasive silica having an acid pH in thecomposition, compositions of enhanced viscosity stability are obtained.Prophy silica available from Grace, offered as Sylodent™, can be usedwith various embodiments of the present invention (e.g., Composition 1.0et seq).

The acidic silica abrasive is included in the dentifrice components at aconcentration of about 2 to about 35% by weight; about 3 to about 20% byweight, about 3 to about 15% by weight, about 10 to about 15% by weight.For example, the acidic silica abrasive may be present in an amountselected from 2 wt. %, 3 wt. %, 4% wt. %, 5 wt. %, 6 wt. %, 7 wt. %, 8wt. %, 9 wt. %, 10 wt. %, 11 wt. %, 12 wt. %, 13 wt. %, 14 wt. %, 15 wt.%, 16 wt. %, 17 wt. %, 18 wt. %, 19 wt. %, 20 wt. %.

A commercially available acidic silica abrasive is Sylodent 783available from W. R. Grace & Company, Baltimore, Md. Sylodent 783 has apH of 3.4-4.2 when measured as a 5% by weight slurry in water. For usein the present invention, the silica material has an average particlesize of less than 10 microns, e.g., 3-7 microns, e.g. about 5.5 microns.For example a small particle silica may have an average particle size(D50) of 2.5-4.5 microns.

The composition may also include any silica suitable for oral carecompositions, such as precipitated silicas or silica gels. For examplesynthetic amorphous silica. Silica may also be available as a thickeningagent, e.g., particle silica. For example, the silica can also be smallparticle silica (e.g., Sorbosil AC43 from PQ Corporation, Warrington,United Kingdom). However the additional abrasives are preferably notpresent in a type or amount so as to increase the RDA of the dentifriceto levels which could damage sensitive teeth, e.g., greater than 130.

The invention may also comprise a commercially available cleaning silicain certain embodiments of the invention (e.g., any of Composition 1.0,et seq). Zeodent 114 offered by J. M. Huber Finland Oy Telakkatie 5FIN-49460 Hamina, is one such commercially available silica.

Water

Water is present in the oral compositions of the invention. Water,employed in the preparation of commercial oral compositions should bedeionized and free of organic impurities. Water commonly makes up thebalance of the compositions and includes 5% to 45%, e.g., 10% to 20%,e.g., 25-35%, by weight of the oral compositions. This amount of waterincludes the free water which is added plus that amount which isintroduced with other materials such as with sorbitol or silica or anycomponents of the invention. The Karl Fischer method is a one measure ofcalculating free water.

Humectants

Within certain embodiments of the oral compositions (e.g., Composition1.0 et seq), it is also desirable to incorporate a humectant to reduceevaporation and also contribute towards preservation by lowering wateractivity. Certain humectants can also impart desirable sweetness orflavor to the compositions. The humectant, on a pure humectant basis,generally includes 15% to 70% in one embodiment or 30% to 65% in anotherembodiment by weight of the composition.

Suitable humectants include edible polyhydric alcohols such as glycerin,sorbitol, xylitol, propylene glycol as well as other polyols andmixtures of these humectants. Mixtures of glycerin and sorbitol may beused in certain embodiments as the humectant component of thecompositions herein.

The present invention in its method aspect involves applying to the oralcavity a safe and effective amount of the compositions described herein.

The compositions and methods according to the invention (e.g.,Composition 1.0 et seq) can be incorporated into oral compositions forthe care of the mouth and teeth such as toothpastes, transparent pastes,gels, mouth rinses, sprays and chewing gum.

In some embodiments, the present invention provides an oral carecomposition comprising: a basic amino acid in free or salt wherein theamino acid is selected from arginine, lysine, and a combination thereof;a combination of zinc ion sources; and from about 0.75 wt. % to about 2wt. % of a chelating system. In some embodiments, the chelating systemcomprises a phosphate. In some embodiments, the phosphate comprisestetrasodium pyrophosphate.

Some embodiments provide compositions further comprising a thickeningsystem comprising: from about 0.1 wt. % to about 2 wt. % of a nonioniccellulose ether; and from about 0.25 wt. % to about 1 wt. % of apolysaccharide gum.

In some embodiments, the nonionic cellulose ether compriseshydroxyethylcellulose. In further embodiments, the oral care compositioncomprises from about 0.5 wt. % to about 1 wt. % ofhydroxyethylcellulose. Still further embodiments provide oral carecompositions comprising from about 0.6 wt. % to about 0.8 wt. % ofhydroxyethylcellulose. In some embodiments, the hydroxyethylcellulosehas a viscosity, measured at 2% in water at 25° C., of from about 4500to 6500 cps. In some embodiments, the hydroxyethylcellulose having aviscosity, measured at 2% in water at 25° C., of from about 4500 to 6500cps is present in the amount of from about 0.1 wt. % to about 0.3 wt. %,of the oral care composition. In some embodiments, thehydroxyethylcellulose having a viscosity, measured at 2% in water at 25°C., of from about 150 to 450 cps, is present in the amount of from about0.5 wt. % to about 1 wt. %.

In some embodiments, the polysaccharide gum is xanthan gum. In someembodiments, the oral care composition comprises from about 0.3 wt. % toabout 0.8 wt. % of xanthan gum.

In some embodiments, the oral care composition comprises about 1.0 wt. %zinc oxide; about 0.5 wt. % zinc citrate; about 1.5 wt. % L-arginine;from about 0.75 wt. % to about 2 wt. % of tetrasodium pyrophosphate.

In further embodiments, the oral care composition loses less than about45% of its initial viscosity after 13 weeks. In some embodiments, theoral care composition loses less than about 40% of its initial viscosityafter 13 weeks. In other embodiments, the oral care composition losesless than about 35% of its initial viscosity after 13 weeks. In yetother embodiments, the oral care composition loses less than about 30%of its initial viscosity after 13 weeks. In some embodiments, the oralcare composition loses less than about 25%, 20%, 15%, 10%, 5% or 3% ofits initial viscosity after 13 weeks.

In some embodiments, the oral care composition has a G′/G″ ratio ofgreater than 0.5. In some embodiments, the oral care composition has aG′/G″ ratio of greater than 0.75. In some embodiments, the oral carecomposition has a G′/G″ ratio of greater than 1. In some embodiments,the oral care composition has a G′/G″ ratio of greater than 1.5. In someembodiments, the oral care composition has a G′/G″ ratio of less than 2.In some embodiments, the oral care composition has a G′/G″ ratio of lessthan 1.5. In some embodiments, the oral care composition has a G′/G″ratio of less than 1.

In some embodiments, the oral care composition has a G′/G″ ratio ofbetween about 0.5 and about 2. In some embodiments, the oral carecomposition has a G′/G″ ratio of between about 0.5 and about 1.5. Insome embodiments, the oral care composition has a G′/G″ ratio of betweenabout 0.5 and about 1. Methods of quantifying the elastic modulus (G′),the loss modulus (G″) and G′/G″ ratios are described, for example, in WO2013/089734 A1, the contents of which are hereby incorporated herein byreference in their entirety.

As used throughout, ranges are used as shorthand for describing each andevery value that is within the range. Any value within the range can beselected as the terminus of the range. In addition, all references citedherein are hereby incorporated by reference in their entireties. In theevent of a conflict in a definition in the present disclosure and thatof a cited reference, the present disclosure controls. It is understoodthat when formulations are described, they may be described in terms oftheir ingredients, as is common in the art, notwithstanding that theseingredients may react with one another in the actual formulation as itis made, stored and used, and such products are intended to be coveredby the formulations described.

The following examples further describe and demonstrate illustrativeembodiments within the scope of the present invention. The examples aregiven solely for illustration and are not to be construed as limitationsof this invention as many variations are possible without departing fromthe spirit and scope thereof.

EXAMPLES Example 1

The examples herein detail how the viscosity over time for a compositionwhich exhibits a problem of rapid reduction in viscosity (Run A), iscompared to five compositions which show the stabilized viscosityprovided by the invention (Compositions 1-5 in Table 1).

Viscosity is measured on a Brookfield HADV2 viscometer using a V74 vanespindle. This viscometer applies a user-controlled angular velocity tothe spindle, typically measured in rotations per second (RPM), andreports torque on the shaft of the spindle. Viscosity is then calculatedfrom RPM and torque as explained in the Brookfield Manual (OperatingInstructions) using too conversion parameters SRC (shear rate constant)and SMC (spindle multiplier constant). The conversion parameters aredefined as follows: SMC=290, SRC=0.2723. The test is performed at roomtemperature, and varies between 22 and 25 deg. C. During the test, RPMof the spindle is swept from 200 to 0.5 in 12 steps, 10 seconds perstep. The viscosity reading reported is taken at RPM=1.

Compositions containing zinc oxide, zinc citrate, arginine and afluoride source are prepared as described in Table 1, below. Allcompositions are formulated to provide a 10% pH of 8-8.5 using 0-0.35%phosphoric acid. The composition identified as Run A does not contain asilica abrasive which exhibits an acid pH when measured as an aqueousslurry. The compositions identified as Compositions 1-5 in Table 1(below) contain a silica abrasive which exhibits an acid pH (ProphySilica-Sylodent 783) when measured as an aqueous slurry in varyingamounts, as detailed below.

TABLE 1 Dentifrice Formulations Experiment ID INGREDIENTS Run AComposition 1 Composition 2 Composition 3 Composition 4 Composition 599.0%-101.0% 35 35 35 35 35 35 GLYCERIN - USP, EP VEG DEMINERALIZED Q.S.Q.S. Q.S. Q.S. Q.S. Q.S. WATER PROPHY 0 15 10 5 5 3 SILICA (SYLODENT783) ABRASIVES (e.g., 20 5 10 15 15 17 includes Abrasive silcas, HighCleaning Silicas) SILICA- 6.5 7 7 7 7 7 THICKENER ANIONIC 2 2 2 2 2 2SURFACTANT L-ARGININE 1.5 1.5 1.5 1.5 1.5 1.5 AMPHOTERIC 1.25 1.25 1.251.25 1.25 1.25 SURFACTANT NON-IONIC 0.75 0.75 0.75 0.75 0.75 0.75SURFACTANT ZINC OXIDE 1 1 1 1 1 1 POLYMER 1 1.3 1.3 1.3 1.3 1.3 COLORANT0.75 0.75 0.75 0.75 0.75 0.75 ALKALI 0.5 0.5 0.5 0.5 0.5 0.5 PHOSPHATESALT ZINC 0.5 0.5 0.5 0.5 0.5 0.5 CITRATE TRIHYDRATE PRESERVATIVE 0.40.4 0.4 0.4 0.4 0.4 SODIUM 0.32 0.32 0.32 0.32 0.32 0.32 FLUORIDE - USP,EP 85% SYRUPY 0.35 0 0 0 0 0 PHOSPHORIC ACID - FOOD GRADE FLAVORING 2 22 2 1.82 1.52 AGENT TOTAL 100 100 100 100 100 100 COMPONENTS

The composition identified as Run A displays an initial viscosity whichis initially 500,000 cps to 600,000 cps high, but decreases to under400,000 cps in 2 weeks, and under 200,000 cps at 6 weeks. Surprisingly,the compositions containing a silica abrasive which exhibits an acid pH(Prophy Silica—Sylodent 783) when measured as an aqueous slurry,Compositions 1 to 5 in Table 1 (above), eliminate this undesirablecharacteristic and instead produce viscosities that are stable orincrease over time (See, Table 2 below).

TABLE 2 Viscosity data Experiment ID Run A Composition 1 Composition 2Composition 3 Composition 4 Composition 5 Time Viscosity (cps) 0 491040363489 1 d 539119 211912 300155 272475 5 d 601597 309816 1 wk 627362288561 383245 371651 2 wk 433485 340733 328495 403212 364565 3 wk 343310314325 334292 4 wk 224794 395483 304019 430909 423823 5 wk 375515 338801322698 6 wk 193233 376804 344598 334292 406432 442503 7 wk 334292 9 wk387753 10 wk 351039 364565 11 wk 158451 373583 381956 12 wk 405788357480 13 wk 405788 398059 393550

Upon further investigation, it was found that the silica abrasive whichexhibits an acid pH when measured as an aqueous slurry silica is acidic(pH 3.4-4.2) does not require phosphoric acid to adjust the product pH.Other abrasive silicas and high cleaning silicas are about neutral in pH(pH 7-8) and thus, require phosphoric acid for pH adjustment.

TABLE 3 Compo- Compo- Compo- sition 6 sition 7 sition 8 DemineralizedWater Q.S. Q.S. Q.S. Glycerin - 99.5% 35 35 35 Polymer 1.2 1.2 1.2 ZincOxide 1 1 1 Zinc Citrate 0.5 0.5 0.5 Alkali Phosphate Salt 0.5 0.5 0.5Flavoring agent 1.82 1.82 1.82 Sodium Fluoride 0.32 0.32 0.32 Colorant0.75 0.75 0.75 L-Arginine 1.5 1.5 1.5 Non-Ionic Surfactant 0.5 0.5 0.5Abrasives (e.g., includes Abrasive 8 10 12 Silcas, High CleaningSilicas) Prophy silica (Sylodent 783) 7 5 3 Silica - thickener 7 7 8.5Preservative 0.4 0.4 0.4 Anionic Surfactant 5.7 5.7 5.7 AmphotericSurfactant 1.25 1.25 1.25 Total Components 100 100 100

Upon further investigation, when phosphoric acid is removed from furtherformulations (Compositions 6-8 in Table 3, above), they demonstrateimprovement in viscosity stability, and this viscosity trend remainedrelatively stable from day 1 to 4 weeks when tested at: roomtemperature, 40° C. and 49° C. The data is further detailed in Table 4below.

TABLE 4 Composition 6 Composition 7 Composition 8 Viscosity, Viscosity,Viscosity, 10³ cps 10³ cps 10³ cps 40° 49° 40° 49° 40° 49° RT C. C. RTC. C. RT C. C. 0 471 324 336 0.14 370 197 268 1 363 418 390 200 227 258230 256 263 2 360 430 440 201 243 269 220 250 258 3 325 205 246 245 228277 274 4 314 412 385 224 253 253 227 268 272 6 327 218 233

Example 2

Table 5 (below) describes the formulas for three exemplary compositionsof the present invention (Compositions 9-12) and two comparativeformulas (Comparative Examples I and II).

TABLE 5 Comparative Comparative Composition 9 Composition 10 Composition11 Composition 12 Example I Example II Ingredient Wt % GLYCERIN 35.00035.000 35.000 35.000 35.000 35.000 WATER 31.460 31.2100 30.710 30.21032.210 31.710 ABRASIVE SILICA 10.000 10.000 10.000 10.000 10.000 10.000SILICA-THICKENER 6.000 6.000 6.000 6.000 6.000 6.000 AMORPHOUS SILICA5.000 5.000 5.000 5.000 5.000 5.000 Na-LAURYL SULFATE 2.000 2.000 2.0002.000 2.000 2.000 Flavor 1.500 1.500 1.500 1.500 1.500 1.500 L-ARGININE1.500 1.500 1.500 1.500 1.500 1.500 COCAMIDOPROPYL 1.250 1.250 1.2501.250 1.250 1.250 BETAINE ZINC OXIDE 1.000 1.000 1.000 1.000 1.000 1.000TITANIUM DIOXIDE 0.750 0.750 0.750 0.750 0.750 0.750 XANTHAN GUM 0.4000.400 0.400 0.400 0.400 0.400 SODIUM CMC 1.000 1.000 1.000 1.000 1.0001.000 TETRASODIUM 0.750 1.000 1.500 2.000 — 0.500 PYROPHOSPHATE ZINCCITRATE 0.500 0.500 0.500 0.500 0.500 0.500 TRIHYDRATE POLOXAMER 4070.500 0.500 0.500 0.500 0.500 0.500 BENZYL ALCOHOL 0.400 0.400 0.4000.400 0.400 0.400 PHOSPHORIC ACID 0.350 0.350 0.350 0.350 0.350 0.350SODIUM FLUORIDE 0.320 0.320 0.320 0.320 0.320 0.320 SODIUM SACCHARIN0.300 0.300 0.300 0.300 0.300 0.300 SUCRALOSE 0.020 0.020 0.020 0.0200.020 0.020

Example 3

Table 6 (below) describes the results of viscosity evaluations performedon exemplary compositions of the present invention and two referenceformulas. Viscosity is measured in accordance with the methods describedin paragraph [0053] herein.

TABLE 6 TSPP Concentration (Wt. %) 0% 0.5% 0.75% 1% 1.5% 2% C.E. I C.E.II Comp. 9 Comp. 10 Comp. 11 Comp. 12 Time Viscosity (cP) Initial 191944465046 459508 377273 453452 454741 4 weeks 180139 223191 — 402198 407296402198 8 weeks 206115 242185 390585 475996 447011 441214 13 weeks 187398 237620 296872 447507 440166 436496 Viscosity 2.37 48.90 35.39−18.62 2.93 4.01 Drop (%)

The data described in Table 6 (above) demonstrates the unexpectedstabilizing effects provided by the inventive phosphate systems of thepresent invention.

Example 4

Table 7 (below) describes the formulas for two additional exemplarycompositions of the present invention (Compositions 13 and 14).

TABLE 7 Compo- Compo- sition 13 sition 14 Ingredient Wt % GLYCERIN35.000 35.000 SUCRALOSE 0.0200 0.0200 WATER 31.560 30.560 SODIUMSACCHARIN 0.300 0.300 ABRASIVE SILICA 10.000 10.000 SILICA-THICKENER6.000 6.000 AMORPHOUS SILICA 5.000 5.000 Na-LAURYL SULFATE 2.000 2.000Flavor 1.500 1.500 L-ARGININE 1.500 1.500 COCAMIDOPROPYL BETAINE 1.2501.250 ZINC OXIDE 1.000 1.000 TITANIUM DIOXIDE 0.750 0.750 XANTHAN GUM0.400 0.400 SODIUM CMC 1.000 1.000 HYDROXYETHYL CELLULOSE — — (HEC)TETRASODIUM PYROPHOSPHATE 1.000 2.000 ZINC CITRATE TRIHYDRATE 0.5000.500 POLOXAMER 407 0.500 0.500 BENZYL ALCOHOL 0.400 0.400 85%PHOSPHORIC ACID — — SODIUM FLUORIDE 0.320 0.320

Example 5

Table 8 (below) describes the percentage change in viscosity loss fortwo exemplary compositions of the present invention (Compositions 13 and14). Viscosity is measured in accordance with the methods described inparagraph [0053] hereinabove.

TABLE 8 TSPP Concentration (Wt. %) 1% 2% Comp. 13 Comp. 14 TimeViscosity (cP) Initial 271170 346530 4 weeks 260808 329469 8 weeks278258 332557 13 weeks  272402 338936 Viscosity −0.45 2.19 Drop (%)

The data described in Table 8 (above) shows that compositions of thepresent invention demonstrate minimal viscosity loss over extendedperiods of time.

As used throughout, ranges are used as shorthand for describing each andevery value that is within the range. Any value within the range can beselected as the terminus of the range. In addition, all references citedherein are hereby incorporated by referenced in their entireties. In theevent of a conflict in a definition in the present disclosure and thatof a cited reference, the present disclosure controls.

Unless otherwise specified, all percentages and amounts expressed hereinand elsewhere in the specification should be understood to refer topercentages by weight. The amounts given are based on the active weightof the material.

While the present invention has been described with reference toembodiments, it will be understood by those skilled in the art thatvarious modifications and variations may be made therein withoutdeparting from the scope of the present invention as defined by theappended claims.

1. An oral care composition comprising: a. a basic amino acid in free orsalt form wherein the amino acid is selected from arginine, lysine, anda combination thereof; b. a combination of zinc ion sources; and c. fromabout 0.75 wt. % to about 2 wt. % of a chelating system.
 2. The oralcare composition according to claim 1, comprising from about 1 wt. % toabout 2 wt. % of a chelating system.
 3. The oral care compositionaccording to claim 1, comprising about 0.75 wt. %, about 1 wt. %, about1.25 wt. %, about 1.5 wt. %, about 1.75 wt. %, or about 2 wt. % of achelating system.
 4. The oral care composition according to claim 1,wherein the chelating system comprises a phosphate.
 5. The oral carecomposition according to claim 1, wherein the chelating system comprisestetrasodium pyrophosphate.
 6. The oral care composition according toclaim 1, further comprising a thickening system comprising apolysaccharide gum.
 7. The oral care composition according to claim 6,wherein the polysaccharide gum is xanthan gum and is present in anamount of from about 0.3 wt. % to about 0.8 wt. % of the total weight ofthe oral care composition.
 8. The oral care composition according toclaim 6, wherein the thickening system further comprises from about 5wt. % to about 10 wt. % silica.
 9. The oral care composition accordingto claim 6, wherein the thickening system comprises from about 0.5 wt. %to about 15 wt. % of the oral care composition.
 10. The oral carecomposition according to claim 1, wherein the zinc ion sources comprisezinc oxide and zinc citrate.
 11. The oral care composition according toclaim 1, wherein the amino acid is arginine, and is present at about 1.5wt. %, 5 wt. %, or about 8 wt. %, of the oral care composition.
 12. Theoral care composition according to claim 10, wherein the weight ratio ofzinc oxide to zinc citrate is about 2:1.
 13. The oral care compositionaccording to claim 10, wherein the zinc citrate is in an amount of about0.5 wt. % and zinc oxide is present in an amount of about 1.0 wt. %based on the total weight of the oral care composition.
 14. The oralcare composition according to claim 1, further comprising a fluoride ionsource selected from sodium fluoride, sodium monofluorophosphate, andstannous fluoride.
 15. The oral care composition according to claim 14,wherein the fluoride ion source is present in an amount of from about0.1 wt. % to 2 wt. % of the total weight of the oral care composition.16. The oral care composition according to claim 14, wherein thefluoride ion source provides soluble fluoride in amount of 50 to 25,000ppm fluoride.
 17. The oral care composition according to claim 14,wherein the fluoride ion source provides soluble fluoride in an amountof about 1450 ppm.
 18. The oral care composition according to claim 14,wherein the fluoride ion source is sodium fluoride, and is present in anamount of about 0.32 wt. %.
 19. The oral care composition according toclaim 14, wherein the fluoride ion source comprises stannous fluoride.20. The oral care composition according to claim 14, comprising: a.about 1.0 wt. % zinc oxide; b. about 0.5 wt. % zinc citrate; c. about1.5 wt. % L-arginine; and d. from about 0.75 wt. % to about 2 wt. % oftetrasodium pyrophosphate.
 21. The oral care composition according toclaim 20, further comprising from about 0.3 wt. % to about 0.6 wt. % ofxanthan gum.
 22. The oral care composition according to claim 1 in aform selected from: a toothpaste, a mouthwash, and an oral gel.
 23. Theoral care composition according to claim 1, wherein the oral carecomposition loses less than about 5% of its initial viscosity after 13weeks.
 24. The oral care composition according to claim 1, having aG′/G″ ratio of greater than 1 and less than
 2. 25. A method to improveoral health comprising applying an effective amount of the oral carecomposition according to claim 1 to the oral cavity of a subject in needthereof, wherein the method is effective to: i. reduce or inhibitformation of dental caries, ii. reduce, repair or inhibit early enamellesions, e.g., as detected by quantitative light-induced fluorescence(QLF) or electrical caries measurement (ECM), iii. reduce or inhibitdemineralization and promote remineralization of the teeth, iv. reducehypersensitivity of the teeth, v. reduce or inhibit gingivitis, vi.promote healing of sores or cuts in the mouth, vii. reduce levels ofacid producing bacteria, viii. to increase relative levels ofarginolytic bacteria, ix. inhibit microbial bio film formation in theoral cavity, x. raise and/or maintain plaque pH at levels of at least pH5.5 following sugar challenge, xi. reduce plaque accumulation, xii.treat dry mouth, xiii. enhance systemic health, including cardiovascularhealth, xiv. whiten teeth, xv. reduce erosion of the teeth, xvi.immunize (or protect) the teeth against cariogenic bacteria and theireffects, and/or xvii. clean the teeth and oral cavity.